BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 1881975 · Received October 12, 2010

    Report

    Report Number
    1030489-2010-01318
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MACROSCOPIC AND OPTICAL INSPECTION CONFIRMS THE IMPLANT IS BROKEN INTO MULTIPLE PIECES, WITH AT LEAST ONE PORTION NOT RETURNED FOR ANALYSIS. THE IMPLANT IS BROKEN ON ONE SIDE WITH FRACTURE SURFACE "RAYS" EMANATING FROM THE CENTER OF THE THREADED ATTACHMENT HOLE. WITNESS MARKS ARE ALSO NOTED ON THE TOP FACE OF THE IMPLANT. THIS SUGGESTS THE IMPLANT WAS PRE-LOADED DUE TO MISALIGNMENT OF THE INSERTER TO THE IMPLANT, WHEN STRUCK WITH THE HAMMER, THE DESIGN LIMITS OF THE IMPLANT WERE OVERCOME, RESULTING CRACK PROPAGATION. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEEK SPACER BROKE AFTER TWO TAPS OF THE HAMMER DURING IMPLANTATION. THE BROKEN IMPLANT WAS REPLACED TO A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE SPINAL SYSTEM CAGE MAX MEDTRONIC SOFAMOR DANEK NA H10B3384

    Patients

    Seq Age Sex Outcome Treatment
    1